FDA 510(k) Application Details - K143124

Device Classification Name Dressing, Wound, Drug

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510(K) Number K143124
Device Name Dressing, Wound, Drug
Applicant FOSHAN UNITED MEDICAL TECHNOLOGIES LTD.
89 TAOYUAN EAST ROAD
SHISHAN, NANHAI, FOSHAN 528225 CN
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Contact JOHN CEN
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 10/31/2014
Decision Date 01/26/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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